DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 2, 4-5, 7-8, 12, 14, 17, 19, 24, 26, and 32-43 are cancelled.
Claims 1, 3, 6, 9, 13, 15, 16, 18, 20-23, 25, and 27-31 are amended.
Claims 1, 3, 6, 9, 13, 15, 16, 18, 20-23, 25, and 27-31 are being examined in this office action.
Claim Objections
Claim 15 is objected to because of the following informalities:
Claim 15 states the limitation "the state of the apparatus being filling" this should read "the state of the apparatus being filled".
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 25, 27, and 28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 25, the limitation “a delivery-start-threshold amount of time” is unclear. Examiner interprets a delivery-start-threshold amount of time to mean a maximum known amount of time the plunger takes to travel from the top of the reservoir to a known location of the sensor.
Claims 27 and 28 similarly recite the limitation “a delivery-start-threshold amount of time”, Examiner interprets a delivery-start-threshold amount of time to mean a maximum known amount of time the plunger takes to travel from the top of the reservoir to a known location of the sensor.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 6, 9, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rosskopf (US 4560979 A).
Regarding Claim 1, Rosskopf discloses a therapeutic substance delivery apparatus (Fig. 1) comprising:
a housing (14);
a reservoir (15) disposed at least partially within the housing and configured to hold a therapeutic substance (Col. 3 Lines 1-5);
a position sensor (21, “The sensor 21 may be, for example, a microswitch actuated by a contact cam, or it may be a photocell, a magnetic switch or the like.” – Col. 3 Lines 9-11) having at least three discrete states (examiner interprets sensor 21, which is connected to housing 11, interacts with activator 22 fastened to slide 13 in order to correspond to three discrete states);
a plunger (16), slidable within the reservoir (Fig. 1, Col. 2 Line 66 through Col. 3 Line 4);
a plunger-sensor engagement interface (21, 22) that is coupled to the plunger within the reservoir and extends from within the reservoir to outside of the reservoir (22 coupled to reservoir via 19, Fig. 1), wherein the plunger and the position sensor are arranged such that the plunger-sensor engagement interface causes the position sensor to change states as the plunger slides within the reservoir (Col. 3 Lines 6-11, Fig. 1); and
control circuitry (23) configured to identify a new state indication of the apparatus based on (a) a change in state of the position sensor (Col. 3 Lines 15-17), or (b) a previous or current state of the apparatus in combination with a threshold amount of time having elapsed without the position sensor changing state (Col. 3 Lines 15-17, examiner interprets that microprocessor 23 is capable of determining time elapsed without receiving signal that sensor has changed states),
wherein:
a first state S1 of the discrete states of the position sensor is a non-triggered state of the position sensor (Fig. 1, activator 22 not in contact with sensor 21),
a second state S2 of the discrete states of the position sensor is a triggered state of the position sensor that is indicative of the plunger moving distally within the reservoir (when activator 22 is sliding away from syringe outlet 20, activator triggers sensor 21 in a first direction, see annotated Fig. 1 below), and
a third state S3 of the discrete states of the position sensor is a triggered state of the position sensor that is indicative of the plunger moving proximally within the reservoir (when activator 22 is sliding toward syringe outlet 20, activator triggers sensor 21 in a second direction, annotated Fig. 1).
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Regarding Claim 3, Rosskopf discloses the apparatus according to claim 1, wherein the position sensor has exactly three discrete states (sensor 21 interacts with activator 22 to determine three discrete states), the exactly three discrete states being the first state S1 (Fig. 1, activator 22 not in contact), the second state S2 (when activator 22 is sliding away from syringe outlet 20, activator triggers sensor 21 in a first direction, annotated Fig. 1), and the third state S3 (when activator 22 is sliding toward syringe outlet 20, activator triggers sensor 21 in a second direction, annotated Fig. 1).
Regarding Claim 6, Rosskopf discloses the apparatus according to claim 1, wherein:
the plunger and the position sensor are arranged such that distal movement of the plunger from an initial proximal position within the reservoir (position where syringe piston 16 would be closest to syringe outlet 20 in Fig. 1) to an intermediate position within the reservoir causes the plunger-sensor engagement interface to change the state of the position sensor from the first state S1 of the discrete states to the second state S2 of the discrete states (when syringe piston 16 slides in the first direction, activator 22 triggers sensor 21 to go from the first state S1 to the second state S2), and
the plunger and the position sensor are arranged such that distal movement of the plunger past the intermediate position to a post-intermediate position within the reservoir causes the plunger-sensor engagement interface to change the state of the position sensor from the second state S2 back to the first state S1 (additional movement of syringe piston 16 causes activator 22 to move past sensor 21 and changes state from second state S2 back to first state S1).
Regarding Claim 9, Rosskopf discloses the apparatus according to claim 6, wherein:
the plunger and the position sensor are arranged such that, subsequently to the position sensor changing from the second state S2 back to the first state S1, proximal movement of the plunger within the reservoir causes the plunger-sensor engagement interface to change the state of the position sensor from the first state S1 to the third state S3 of the discrete states (when activator 22 slides in the second direction, sensor 21 is triggered from the first state S1 to the third state S3, annotated Fig. 1), and
the plunger and the position sensor are arranged such that, subsequently to the position sensor changing from the first state S1 to the third state S3, further proximal movement of the plunger causes the plunger-sensor engagement interface to change the state of the position sensor from the third state S3 back to the first state S1 (further movement of activator 22 in the second direction causes sensor to go from the third state S3 back to the first state S1, annotated Fig. 1).
Regarding Claim 11, Rosskopf discloses the apparatus according to claim 1, wherein the apparatus is in a sleep state (examiner interprets that a sleep state is when the syringe piston 16 is closest to syringe outlet 20, before infusion liquid is introduced into syringe cylinder 15) when packaged for commercial sale, and wherein the position sensor is in the first state S1 when the apparatus is in the sleep state, and wherein the control circuitry is configured to (a) identify that the apparatus is in an expired state if a sleep-threshold amount of time has elapsed without the position sensor changing state from the first state S1 (microprocessor 23 is able to receive output signal of sensor 21, Col. 3 Lines 15-17, examiner interprets that microprocessor 23 is capable of determining amount of time that the sensor is in the first state S1, and identify an expired state if the determined time is above a sleep-threshold amount), and (b) in response thereto, disable the apparatus (microprocessor is able to determine the apparatus is in an expired state and, in response, stop drive motor to stop the delivery of fluid). Examiner notes the phrase “packaged for commercial sale” is intended use and is given limited patentable weight for the use of itself as the prior art is capable of being sold commercially.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 13, 15, 16, 18, 20, 22, 23, 25, and 27-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosskopf in view of Kondo (Pub. No. US 20170368269 A1).
Regarding Claim 13, Rosskopf discloses the apparatus according to claim 1, wherein:
(b) prior to the filling of the reservoir the apparatus is in a sleep state (examiner interprets that a sleep state is when the syringe piston 16 is closest to syringe outlet 20, before infusion liquid is introduced into syringe cylinder 15), the plunger is disposed at an initial proximal position within the reservoir (syringe piston 16 is closest to syringe outlet 20), and the position sensor is in the first state S1 (sensor 21 is not yet triggered by activator 22),
(c) filling the reservoir with the therapeutic substance causes the plunger to slide in a distal direction from the initial proximal position (as infusion fluid fills syringe cylinder 15, syringe piston 16 moves in first direction in annotated Fig. 1),
(d) the plunger and the position sensor are arranged such that as the plunger slides in the distal direction, the plunger-sensor engagement interface causes the position sensor to change state from the first state S1 to the second state S2 (as infusion fluid fills syringe cylinder 15, syringe piston 16 moves to second direction where activator 22 triggers sensor 21 from first state S1 to second state S2), and
(e) the control circuitry is configured to identify that the apparatus is awake and in a filling state in response to the position sensor changing state from the first state S1 to the second state S2 (microprocessor 23 is able to receive output signal of sensor 21, Col. 3 Lines 15-17, activator 22 triggers sensor 21 in response to being filled with an infusion fluid, microprocessor is able to recognize the change from first state S1 to second state S2 and determine the apparatus is awake).
Rosskopf does not expressly discloses wherein (a) the housing is shaped to define a filling port in fluid communication with the reservoir, and wherein the reservoir is configured to be filled with the therapeutic substance via the filling port.
Kondo teaches wherein (a) the housing (16) is shaped to define a filling port (26) in fluid communication with the reservoir (18, Fig. 1), and wherein the reservoir is configured to be filled with the therapeutic substance via the filling port (Paragraph [0024]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus disclosed by Rosskopf wherein (a) the housing is shaped to define a filling port in fluid communication with the reservoir, and wherein the reservoir is configured to be filled with the therapeutic substance via the filling port as taught by Kondo so that the apparatus is able to continuously or intermittently administer medicinal liquid (Kondo, Paragraph [0007]).
Regarding Claim 15, modified Rosskopf in view of Kondo discloses the apparatus according to claim 13, wherein:
the plunger and the position sensor are arranged such that upon completion of the reservoir being filled with a threshold volume of the therapeutic substance (Kondo, “appropriate amount of medicinal liquid” – Paragraph [0040]), the plunger-sensor engagement interface causes the position sensor to change state from the second state S2 back to the first state S1 (Rosskopf, activator 22 would move past sensor 21 after being filled with a threshold volume of the infusion liquid, going from the second state S2 back to the first state S1, Fig. 1), and
the control circuitry is configured to identify that a filling error has occurred in response to (i) the state of the apparatus being filling (Kondo, fluid entering from lead-in port 26), in combination with (ii) a filling-threshold amount of time having elapsed from when the position sensor changes state from the first state S1 to the second state S2 without the position sensor changing state from the second state S2 back to the first state S1 (Rosskopf, microprocessor 23 is able to receive signal from the sensor 21 and determine infusion rate, Col. 3 Lines 15-31, while being filled with fluid, the microprocessor would be able to measure the time sensor is triggered in the second state S2 from the first state S1 and determine if a filling error has occurred if enough time had elapsed).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus disclosed by Rosskopf wherein the plunger and the position sensor are arranged such that upon completion of the reservoir being filled with a threshold volume of the therapeutic substance as taught by Kondo so that a user is able to fill an empty reservoir with a desired amount of medicinal liquid (Kondo, Paragraph [0040]).
Regarding Claim 16, modified Rosskopf in view of Kondo discloses the apparatus according to claim 13, wherein the plunger and the position sensor are arranged such that upon completion of the reservoir being filled with at least a threshold volume of the therapeutic substance (Kondo, “appropriate amount of medicinal liquid” – Paragraph [0040]), the plunger-sensor engagement interface causes the position sensor to change state from the second state S2 back to the first state S1 (Rosskopf, when threshold amount of fluid fills syringe cylinder 15, activator 22 moves past sensor in the first direction going from the second state S2 to first state S1, annotated Fig. 1), and wherein the control circuitry is configured to identify that the apparatus is in a filling-complete state in response to the position sensor changing state from the second state S2 back to the first state S1 (microprocessor 23 able to receive signal from sensor 22, Col. 3 Lines 15-17, microprocessor is able to determine that apparatus is in a filling-complete state after going from second state S2 to first state S1).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus disclosed by Rosskopf wherein the plunger and the position sensor are arranged such that upon completion of the reservoir being filled with a threshold volume of the therapeutic substance as taught by Kondo so that a user is able to fill an empty reservoir with a desired amount of medicinal liquid (Kondo, Paragraph [0040]).
Regarding Claim 18, modified Rosskopf in view of Kondo discloses the apparatus according to claim 16, wherein:
the plunger and the position sensor are arranged such that, subsequently to the plunger-sensor engagement interface causing the position sensor to change state from the first state S1 to the second state S2, the plunger-sensor engagement interface maintains engagement with the position sensor, so as to maintain the position sensor in the second state S2, until the reservoir has been filled with the threshold volume of the therapeutic substance (Kondo, “appropriate amount of medicinal liquid” – Paragraph [0040]) examiner interprets that the activator disclosed by Rosskopf is able to maintain contact with the sensor in the second state S2 until the syringe cylinder is filled with the threshold volume, and
the plunger and the position sensor are arranged such that further distal movement of the plunger subsequently to the reservoir being filled with the threshold volume of the therapeutic substance causes the plunger-sensor engagement interface to terminate engagement with the position sensor, causing the position sensor to switch from the second state S2 back to the first state S1 (Rosskopf, after syringe cylinder is filled with the threshold volume, syringe piston and activator moves in the first direction past sensor and back into the first state S1, annotated Fig. 1).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus disclosed by Rosskopf wherein the plunger and the position sensor are arranged such that upon completion of the reservoir being filled with a threshold volume of the therapeutic substance as taught by Kondo so that a user is able to fill an empty reservoir with a desired amount of medicinal liquid (Kondo, Paragraph [0040]).
Regarding Claim 20, modified Rosskopf in view of Kondo discloses the apparatus according to claim 13, wherein:
(a) upon completion of the reservoir being filled with at least a threshold volume of the therapeutic substance, the apparatus is in a filling-complete state (Kondo, tubular body 18 filled with an appropriate amount of medicinal liquid, Paragraph [0040]), and the position sensor is in the first state S1 (Rosskopf, activator 22 to the right of sensor 21 in Fig. 1),
(b) subsequently to the apparatus being in the filling-complete state, the control circuitry is configured to initiate a delivery-started state of the apparatus (Rosskopf, Col. 3 Lines 12-13 after medicinal liquid fills syringe cylinder to an appropriate amount, microprocessor is able to start delivery of the fluid) in which the control circuitry drives the therapeutic substance delivery apparatus to deliver the therapeutic substance from the reservoir to a subject by driving the plunger to slide proximally within the reservoir (Rosskopf, Col. 3 Lines 1-5), and
(c) the plunger and the position sensor are arranged such that as the plunger slides proximally the plunger-sensor engagement interface causes the position sensor to change state from the first state S1 to the third state S3 (Rosskopf, when syringe piston 16 pushes infusion out of the syringe cylinder, activator 22 triggers sensor 21 in the second direction to the third state S3).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus disclosed by Rosskopf wherein the plunger and the position sensor are arranged such that upon completion of the reservoir being filled with a threshold volume of the therapeutic substance as taught by Kondo so that a user is able to fill an empty reservoir with a desired amount of medicinal liquid (Kondo, Paragraph [0040]).
Regarding Claim 22, modified Rosskopf in view Kondo discloses the apparatus according to claim 20, wherein the control circuitry is further configured to (a) receive an input indicating an intended volume of the therapeutic substance to be filled within the reservoir (Rosskopf, Col. 3 Lines 13-17), and (b) in response to the received input, determine the length of an expected wait-time between the control circuitry initiating the delivery-started state of the apparatus and the plunger-sensor engagement interface causing the position sensor to change state from the first state S1 to the third state S3 (Rosskopf, Col. 3 Lines 21-38, microprocessor is able to determine a time elapsed between beginning delivery of the known volume of fluid to when sensor is triggered into the third state S3).
Regarding Claim 23, modified Rosskopf in view of Kondo discloses the apparatus according to claim 22, wherein the control circuitry is configured to:
in response to (i) the current state of the apparatus being delivery-started (Rosskopf, when fluid starts being delivered from syringe cylinder), in combination with (ii) the position sensor changing state from the first state S1 to the third state S3 (Rosskopf, when activator 22 triggers sensor 21 to the third state S3 in the second direction) prior to the expected wait-time having elapsed (Rosskopf, time elapsed between beginning of fluid delivery to triggering of sensor into third state S3), terminate the delivery of the therapeutic substance to the subject (examiner interprets that the microprocessor of Rosskopf would be able to signal the drive motor to terminate delivery of infusion fluid before the expected wait-time has elapsed, Fig. 1).
Regarding Claim 25, modified Rosskopf in view of Kondo discloses the apparatus according to claim 22, wherein:
the control circuitry is configured to identify that the reservoir has been filled with a volume of therapeutic substance that is larger than the intended volume (Rosskopf, Col. 3 Lines 12-15, microprocessor 23 able to determine a predefined syringe volume, microprocessor would be capable of determining that fluid entered into the infusion syringe is larger than the inputted volume) in response to (i) the current state of the apparatus being delivery-started (Rosskopf, when fluid starts being delivered from syringe cylinder), in combination with (ii) the position sensor changing state from the first state S1 to the third state S3 after an amount of time that is longer than the expected wait-time but shorter than a delivery-start-threshold amount of time (Rosskopf, microprocessor 23 able to determine wait-time for an inputted volume of fluid and compare that to a known time it would take to deliver a maximum volume of fluid before sensor changes to the third state S3), and
the control circuitry is configured to terminate the delivery of the therapeutic substance to the subject in response to the reservoir having been filled with the volume of therapeutic substance larger than the intended volume (Rosskopf, microprocessor 23 capable of sending signal to drive motor to stop delivery of infusion fluid if determined volume is greater than the expected volume, Fig. 1).
Regarding Claim 27, modified Rosskopf in view of Kondo discloses the apparatus according to claim 22, wherein:
(a) the control circuitry is configured to identify that the reservoir has been filled with a volume of therapeutic substance that is larger than the intended volume in response to (i) the current state of the apparatus being delivery-started (Rosskopf, when fluids starts to be delivered from syringe cylinder), in combination with (ii) the position sensor changing state from the first state S1 to the third state S3 after an amount of time that is longer than the expected wait-time but shorter than a delivery-start-threshold amount of time (Rosskopf, microprocessor 23 able to determine wait-time for an inputted volume of fluid and compare that to a known time it would take to deliver a maximum volume of fluid before sensor changes to the third state S3),
(b) the control circuitry is configured to compensate for the difference in volume between the intended volume and the volume of therapeutic substance within the reservoir that is larger than the intended volume by terminating the delivery of the therapeutic substance to the subject upon delivering the intended volume to the subject (Rosskopf, drive of the infusion syringe is controlled by microprocessor, Col. 3 Lines 12-17, after inputting a desired syringe volume, microprocessor would be able to deliver intended amount before terminating drive motor, ceasing fluid delivery),
(c) the plunger and the position sensor are arranged such that, in response to the reservoir being filled with the intended volume (Kondo, “appropriate amount of medicinal liquid” – Paragraph [0040]), upon delivering the intended volume to the subject the plunger-sensor engagement interface causes the position sensor to change state from the third state S3 back to the first state S1 (Rosskopf, activator 22 moving past sensor in the second direction in annotated Fig. 1), and
(d) in response to the identification that the reservoir has been filled with a volume of therapeutic substance that is larger than the intended volume, upon delivering the intended volume to the subject, the control circuitry is configured to terminate the delivery of the therapeutic substance to the subject notwithstanding the position sensor remaining in the third state S3 (Rosskopf, microprocessor is able to stop delivery of fluid when sensor is in the third state S3, Col. 3 Lines 12-13).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus disclosed by Rosskopf wherein the plunger and the position sensor are arranged such that upon completion of the reservoir being filled with a threshold volume of the therapeutic substance as taught by Kondo so that a user is able to fill an empty reservoir with a desired amount of medicinal liquid (Kondo, Paragraph [0040]).
Regarding Claim 28, Rosskopf in view of Kondo discloses the apparatus according to claim 22, wherein the control circuitry is configured to:
identify that a delivery-start error has occurred in response to (i) the current state of the apparatus being delivery-started (Rosskopf, when fluid starts being delivered from syringe cylinder), in combination with (ii) a delivery-start-threshold amount of time having elapsed (Rosskopf, maximum known amount of time the plunger takes to travel from the top of the syringe cylinder to the known location of the sensor) from when the control circuitry initiated the delivery-started state without the position sensor changing state from the first state S1 to the third state S3 (Rosskopf, when microprocessor initiates delivery of fluid, before activator 22 triggers sensor 21 into the third state S3), and
in response thereto, disable the apparatus (Rosskopf, microprocessor controls the drive of the infusion syringe pump, Col. 3 Lines 12-13, microprocessor would be able to determine that enough time had passed without the sensor changing states to the third state S3 before signaling drive motor to terminate, Fig. 1).
Regarding Claim 29, Rosskopf in view of Kondo discloses the apparatus according to claim 22, wherein the control circuitry is configured to identify that the apparatus is in a delivery-in-progress state, in which therapeutic substance is being delivered from the reservoir to the subject, in response to the position sensor changing state from the first state S1 to the third state S3 subsequently to the control circuitry initiating the delivery-started state of the apparatus and the expected wait-time having elapsed (Rosskopf, state in which fluid is being delivered to patient after infusion pump 10 initiates movement of syringe piston 16 in the second direction, after determined time from when delivery of fluid has started and after sensor has been triggered to the third state S3).
Regarding Claim 30, Rosskopf in view of Kondo discloses the apparatus according to claim 29, wherein the plunger and the position sensor are arranged such that upon completion of delivery of the intended volume of therapeutic substance from the reservoir (Rosskopf, after all fluid has been delivered from syringe cylinder), the plunger-sensor engagement interface causes the position sensor to change state from the third state S3 back to the first state S1 (Rosskopf, activator 22 moves past sensor 21 in the second direction), and wherein the control circuitry is configured to identify that the apparatus is in a delivery-complete state in response to the position sensor changing state from the third state S3 to the first state S1 (Rosskopf, after activator 22 has triggered sensor 21 in the second direction, microprocessor 23 indicates that apparatus is back in the first state S1 and in a delivery-complete state).
Regarding Claim 31, Rosskopf in view of Kondo discloses the apparatus according to claim 30, wherein the control circuitry is configured to identify that a delivery-progress error has occurred in response to (i) the current state of the apparatus being delivery-in-progress (Rosskopf, when fluid delivery has initiated, but sensor is not yet in the first state S1 after being triggered in the third state S3), in combination with (ii) a delivery-progress-threshold amount of time (Rosskopf, maximum amount of time it takes fluid to empty from syringe cylinder 15 when full) having elapsed from when the position sensor changes state from the first state S1 to the third state S3 (Rosskopf, activator 22 moving in the second direction to trigger sensor into the third state S3) without the position sensor changing state from the third state S3 back to the first state S1 (Rosskopf, when activator 22 maintains contact with sensor 21).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosskopf in view of Kondo, further in view of Buck, JR. et al. (Pub. No. US 20100156633 A1, herein Buck, JR.).
Regarding Claim 21, modified Rosskopf in view of Kondo discloses the apparatus according to claim 20, wherein the control circuitry is configured to identify that there is a leak in the reservoir in response to the position sensor changing state from the first state S1 to the third state S3 prior to the control circuitry initiating the delivery-started state of the apparatus (Rosskopf, microprocessor 23 can determine if apparatus is in the third state S3 before an initiating delivery of infusion liquid, thus indicating a leak).
Modified Rosskopf in view of Kondo does not expressly disclose in response to the identification that there is a leak, disable the apparatus.
Buck, JR. teaches in response to the identification that there is a leak (“blocked infusion set, a damaged cartridge 70, and/or a dirty or damaged piston rod” - Paragraph [0070]), disable the apparatus (“he processor 28 determines that an operating error has been detected, the process 100 advances from step 110 to step 112, where processor 28 is operable to disable, e.g., permanently, operation of the pump 14” – Paragraph [0085]).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the claimed invention to modify the apparatus disclosed by modified Rosskopf in view of Kondo where in response to the identification that there is a leak, disable the apparatus as taught by Buck, JR. so that delivery of a fluid may be terminated in response to identifying an error with the apparatus (Buck, Jr., Paragraph [0085]).
Response to Arguments
Applicant’s arguments filed May 28, 2025 have been fully considered.
In regards to applicant’s argument
“the drawings were objected to due to the reference number 36 being omitted in Fig. 1. Applicant is filing herewith a Replacement Sheet with a corrected version of Fig. 1. Applicant respectfully submits that this Replacement sheet obviates the drawing objection of record.”
This argument is persuasive and the drawing objection in regards to reference number 36 is withdrawn.
In regards to applicant’s argument that
“Claims 1, 3, and 6 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite. The Office Action asserted that the states of the position sensor were not clearly defined and that it was difficult to discern how many states the position sensor can have, and how each state is identified. While not conceding the correctness of the rejection, Applicant has amended claim 1 to recite discrete first, second, and third states of the position sensor and how each of these three states are identified.”
This argument is persuasive and the 35 U.S.C. 112(b) rejection for claims 1, 3, 6, and resulting dependent claims are withdrawn. However, a new 35 U.S.C. 112(b) rejection for claims 25, 27, and 28 are stated above.
In regards to applicant’s argument that
“Claims 1, 3, 13, 16, 20, and 32 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2017/0368269 to Kondo (hereinafter "Kondo").
The Office Action asserted that the combination of Kondo's initial-position sensor 74 and predetermined-position sensor 76 read on the position sensor of claim 1 as previously pending.
While not conceding the correctness of the rejection, Applicant has herein amended claim 1 to clarify the states of the position sensor.”
This argument is persuasive and the 35 U.S.C. 102(a)(1) rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Rosskopf.
In regards to applicant’s argument that
“Claim 11 was rejected under 35 U.S.C. 103 as being unpatentable over Kondo in view of US 2010/0156633 to Buck, Jr. (hereinafter "Buck, Jr.").
Claim 15 was rejected under 35 U.S.C. 103 as being unpatentable over Kondo in view of US 2013/0177455 to Kamen.
Claim 21 was rejected under 35 U.S.C. 103 as being unpatentable over Kondo in view of US 8,957,674 to Genoud, and further in view of Buck, Jr.
Claims 22 and 29 were rejected under 35 U.S.C. 103 as being unpatentable over Kondo in view of US 4,560,979 to Rosskopf (hereinafter "Rosskopf').
Claims 23 and 28 were rejected under 35 U.S.C. 103 as being unpatentable over Kondo in view of Rosskopf, and further in view of US 5,236,416 to McDaniel (hereinafter "McDaniel").
Applicant notes that all of the above rejections under 35 U.S.C. 103 rely on Kondo as applied by the Office Action to claim 1 or a claim dependent on claim 1. As described hereinabove, Applicant respectfully submits that Kondo does not disclose or suggest the three states recited in currently amended claim 1. The cited secondary references fail to remedy these deficiencies of Kondo. As such, Applicant respectfully submits that none of the proposed modifications in the rejections under 35 U.S.C. 103 would result in all of the recited claim elements. “
This argument is persuasive and the 35 U.S.C. 103 rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Rosskopf, Kondo, and Buck, JR.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt. Fri. off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARK GOLOVAN/ Patent Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783